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Status:

RECRUITING

A Study to Test Whether BI 1815368 Helps People With an Eye Condition Called Diabetic Macular Edema

Lead Sponsor:

Boehringer Ingelheim

Conditions:

Macular Edema

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

This study is open to adults 18 and older with an eye condition called diabetic macular edema. People are required to have a specific type of diabetic macular edema called centre-involved diabetic mac...

Eligibility Criteria

Inclusion

  • Inclusion criteria:
  • ≥18 years of age
  • Diagnosis of diabetes mellitus (DM) (type 1 or type 2), Haemoglobin A1C (HbA1c) \<12% treated with stable medication for at least 30 days prior to Day 1; no already-set plans for major changes in DM medication (e.g. start of new medication) at the time of screening and baseline
  • Centre-involved diabetic macular edema (CI-DME) confirmed on spectral domain optical coherence tomography (SD-OCT) with central subfield foveal thickness (CST) ≥320 µm for male and ≥305 µm for female participants in the study eye at screening
  • Best corrected visual acuity (BCVA) visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye between 24 and 78 (Snellen equivalent range 20/320 to 20/32) at screening Further inclusion criteria apply.
  • Exclusion criteria:
  • Macular edema considered to be due to other causes than CI-DME in the study eye
  • Proliferative diabetic retinopathy or iris neovascularisation (including the anterior chamber angle) in the study eye
  • Any intravitreal (IVT) anti-vascular endothelial growth factor (VEGF) treatment within 4 months before Day 1 (other than Vabysmo® or Eylea® HD), and within 6 months before Day 1 for Vabysmo® or Eylea® HD, and/or more than 4 prior IVT injections with anti-VEGF treatment in total in the study eye
  • Any history of panretinal photocoagulation treatment, macular laser photocoagulation, vitreoretinal surgery, IVT or periocular corticosteroid treatment (within 12 months before Day 1), history of Iluvien® or Ozurdex® implants before Day 1, or topical steroid or NSAID treatment (within 30 days before Day 1)
  • Active ocular inflammation of any history of intraocular inflammation within 1 year
  • Aphakia or total absence of the posterior capsule; Yttrium aluminium garnet (YAG) laser capsulotomy in the study eye is permitted if more than 2 months prior to Day 1 Further exclusion criteria apply.

Exclusion

    Key Trial Info

    Start Date :

    June 5 2025

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ESTIMATED

    End Date :

    September 29 2027

    Estimated Enrollment :

    300 Patients enrolled

    Trial Details

    Trial ID

    NCT06962839

    Start Date

    June 5 2025

    End Date

    September 29 2027

    Last Update

    January 9 2026

    Active Locations (80)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 20 (80 locations)

    1

    Win Retina

    Arcadia, California, United States, 91006

    2

    Retina Associates of Southern California

    Huntington Beach, California, United States, 92647

    3

    Retinal Consultants Medical Group, Inc

    Modesto, California, United States, 95356

    4

    Doheny Eye Center UCLA Arcadia

    Pasadena, California, United States, 91103